Anchoring system for a catheter

ABSTRACT

An anchoring system secures a catheter to the body of a patient and arrests axial movement of the catheter without impairing fluid flow through the catheter. The anchoring system can include an anchor pad that adheres to the patient&#39;s skin and supports a retainer. The retainer can include interengaging structure that moves the retainer between an open and a closed position. When in the open position, the retainer can receive a portion of the catheter and be subsequently moved to the closed position. The interengaging structure can allow the retainer to receive catheters of various sizes. The retainer can include one or more retention mechanisms to further inhibit axial movement of the catheter relative to the retainer when the catheter is secured therein. The anchoring system can include a mount that allows the retainer to rotate relative to the anchor pad.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/489,594, filed Apr. 17, 2017, now U.S. Pat. No. 10,561,815, which isa continuation of U.S. patent application Ser. No. 12/063,225, filedFeb. 7, 2008, now U.S. Pat. No. 9,642,987, which is a U.S. nationalstage of International Patent Application No. PCT/US2006/034203, filedAug. 31, 2006, which claims the benefit of U.S. Provisional ApplicationNo. 60/713,004, filed Aug. 31, 2005, each of which is herebyincorporated by reference in its entirety.

BACKGROUND 1. Field of the Invention

The present invention relates to an anchoring system for securing amedical article to a patient to inhibit movement or migration of themedical article relative to the patient.

2. Description of Related Art

Hospitalized patients often have limited mobility due either to theircondition or to doctor's orders. Such patients must lie in bed and notmove about their hospital room, even to urinate. As such, a Foleycatheter is often used with the bed-confined patient to drain urine fromthe patient's bladder. Use of a Foley catheter thus eliminates toilettrips as well as reduces bedpan use.

A Foley catheter typically includes two coaxial lumens: a drainage lumenand an inflation lumen. The inflation lumen communicates with aninflation balloon located at the tip of the catheter (i.e., the catheterproximal end). The proximal end of the drainage lumen includes one ormore influent openings to receive urine from the bladder. The lumensusually diverge in a Y-type pattern at the distal end of the catheter toform an effluent port and an inflation port.

In use, a healthcare provider inserts the Foley catheter through theurinary tract of the patient to locate the tip of the catheter withinthe patient's bladder. Although the catheter usually includes asiliconized outer coating as provided by the manufacturer, healthcareproviders often apply further lubricant, such as, for example,water-based jelly. The provider then inflates the balloon by attachingthe inflation port to a source of pressurized working fluid (e.g.,saline solution). Once inflated, a valve, which is located at theinflation port, inhibits the flow of fluid from the inflation lumen andthe balloon to keep the balloon inflated. The inflated balloon isintended to prevent the catheter from unintentionally dislodging fromthe bladder. The healthcare provider then connects the distal end of thedrainage lumen (i.e., its effluent port) to a drainage tube leading to acollection container.

The healthcare provider usually secures the distal end of the catheterto the patient using tape. The healthcare provider commonly places longpieces of tape across the distal end of the catheter in a crisscrosspattern to secure the catheter distal end to the inner thigh of thepatient. This securement is intended to inhibit disconnection betweenthe catheter and the drainage tube, as well as to prevent the catheteror drainage tube from snagging on the bed rail or other objects.

Taped connections, however, often collect contaminants and dirt. Tapealso becomes non-adherent to the siliconized surface of the catheter.Normal protocol therefore requires periodic tape changes in order toinhibit germ growth and restore adherence at the securement site.Frequent tape changes though lead to another problem: excoriation of thepatient's skin. In addition, valuable time is spent applying andreapplying the tape to secure the catheter. And healthcare providersoften remove their gloves when taping because most find the tapingprocedure difficult and cumbersome when wearing gloves. Not only doesthis further lengthen the procedure, but it also subjects the healthcareprovider to possible infection.

SUMMARY

One aspect of the present invention thus involves an anchoring systemfor securing a catheter to a body of a patient, the catheter comprisinga relatively soft tube for insertion into the patient connected to arelatively rigid connector fitting. The anchoring system comprises ananchor pad having an upper surface and a lower surface, at least aportion of the lower surface having adhesive for contacting a patient'sskin. The anchoring system further comprises a retainer rotatablyattached to the upper surface of the anchor pad and comprising a baseand a strap, the strap being sized to wrap around the catheter distal toa Y-site of the catheter. The retainer has an interengaging structurewhich secures the strap such that the catheter is secured to the base.The retainer and catheter contact each other over a contact area toprovide frictional interaction therebetween. The frictional interactionis sufficient to inhibit longitudinal movement of the catheter relativeto the retainer.

Another aspect is an anchoring system for securing a catheter to a bodyof a patient, the catheter comprising a relatively soft tube forinsertion into the patient connected to a relatively rigid connectorfitting. The anchoring system comprises an anchor-pad that has an uppersurface and a lower surface, at least a portion of the lower surface hasan adhesive surface to attach the anchor pad to the body of the patient.The anchoring system further comprises a retainer mounted on the uppersurface of the anchor pad. The retainer is capable of receiving aportion of the catheter. The retainer comprises a base and a strap. Thebase has a contact area. At least a portion of the strap being movablerelative to the base so as to move between an open position and a closedposition. The strap lies above at least part of the contact area when inthe closed position and is sized to wrap around the catheter distal to aY-site of the catheter. The anchoring system further comprises a latchmechanism configured to secure the strap when in the closed positionsuch that the catheter is secured to the base. The retainer and cathetercontacting each other over at least a portion of the contact area toprovide frictional interaction therebetween. The frictional interactionbeing sufficient to inhibit longitudinal movement of the catheterrelative to the retainer.

Another aspect is a method for releasably anchoring a catheter includinga relatively soft tube for insertion into the patient connected to arelatively rigid connector fitting. The method comprises providing ananchoring device having an adhesive lower surface, and a retainercomprising a base and a strap, inserting a distal portion of the medicalarticle into a contact area of the retainer such that at least a portionof the connector fitting lies over the base, and positioning the strapover at least a portion of the medical article. The method furthercomprises securing the strap such that the retainer and medical articlecontact each other over the contact area to provide frictionalinteraction therebetween, the frictional interaction being sufficient toinhibit longitudinal movement of the medical article relative to theretainer and securing the anchoring device to the skin of the patientvia the adhesive lower surface of the anchoring device.

Further aspects, features and advantages of the present invention willbecome apparent from the detailed description of the preferredembodiments that follows.

BRIEF DESCRIPTION OF THE DRAWINGS

The above mentioned and other features of the invention will now bedescribed with reference to the drawings of embodiments of the presentanchoring system. The illustrated embodiments of the anchoring systemare intended to illustrate, but not to limit the invention. The drawingscontain the following figures:

FIG. 1 is a perspective view of an anchoring system in accordance withan embodiment of the present invention.

FIG. 2 is a bottom view of the anchoring system of FIG. 1 .

FIG. 3 is a cross-sectional view of the retainer, taken along the line3-3 of FIG. 1 .

FIG. 4 is an enlarged detail view of a cross-sectional view of arotatable mount of FIG. 3 circumscribed by line 4-4.

FIG. 5 is an enlarged, exploded detail view of the rotatable mount and athrough-hole in the retainer of FIG. 3 .

FIG. 6 is a top plan view of the retainer of FIG. 1 with the strapremoved from the retainer and a catheter aligned above the anchoringsystem.

FIG. 7 is a cross-sectional view of the anchoring system of FIG. 1 , andillustrates the strap in an open position and a catheter aligned abovethe anchoring system for insertion therein.

FIG. 8 is a cross-sectional view of the anchoring system of FIG. 1 , andillustrates the strap in a closed position with the catheter securedwithin the channel of the anchoring system.

FIG. 9 is a perspective view of an anchoring system in accordance withanother embodiment of the present invention, and illustrates a strap ina closed position with a catheter secured within a channel of theanchoring system.

FIG. 10 is a perspective view of the anchoring system of FIG. 9 , andillustrates the strap in the closed position with the catheter removedfrom the channel.

FIG. 11 is a cross-sectional view through the retainer of FIG. 9 , andillustrates the strap in the closed position with the catheter securedto the retainer by interengaging structure.

FIG. 12 is a perspective view of the retainer from FIG. 9 with the strapin an open position.

FIG. 13 is a top view of the retainer from FIG. 12 showing a pluralityof barbs on a portion of the inner surface of the channel.

FIG. 14 is a bottom view of the retainer from FIG. 12 showing athrough-hole in the base of the retainer.

FIG. 15 is a side view of the retainer from FIG. 12 showing a pluralityof ratchet teeth or serrations in the strap of the retainer.

FIG. 16 is a front view of the retainer from FIG. 12 showing a baseportion of the channel.

FIG. 17 is a cross-sectional view of the retainer from FIG. 12 showing areleasable latch mechanism for the strap.

FIG. 18 is a cross-sectional view taken along lines 18-18 in FIG. 16 andshows the through-hole in the base of the retainer.

FIG. 19 is a perspective view of an anchoring system in accordance withanother embodiment of the present invention, and illustrates a strap ina closed position with a catheter secured within a channel of theanchoring system.

FIG. 20 is a perspective view of the anchoring system of FIG. 19 , andillustrates the strap in the closed position with the catheter removedfrom the channel.

FIG. 21 is a cross-sectional view through the retainer of FIG. 19 , andillustrates the strap in a closed position with the catheter secured tothe retainer by interengaging structure.

FIG. 22 is a perspective view of the retainer from FIG. 19 with thestrap in an open position and extending from the retainer base in alateral direction.

FIG. 23 is a top view of the retainer from FIG. 22 showing a pluralityof barbs on a portion of the inner surface of the channel.

FIG. 24 is a bottom view of the retainer from FIG. 22 showing athrough-hole in the base of the retainer.

FIG. 25 is a side view of the retainer from FIG. 22 .

FIG. 26 is a front view of the retainer from FIG. 22 showing an angledlatch mechanism.

FIG. 27 is a cross-sectional view of the retainer from FIG. 22 showingan angled opening through the latch mechanism.

FIG. 28 is a cross-sectional view taken along lines 28-28 in FIG. 26 andshows the through-hole in the base of the retainer.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present embodiments of the medical article anchoring system aredisclosed in the context of an exemplary Foley type catheter. Theprinciples of the present invention, however, are not limited to Foleycatheters. Instead, it will be understood by one of skill in this art,in light of the present disclosure, that the anchoring system andretainer disclosed herein also can be successfully utilized inconnection with other types of medical articles, including other typesof catheters, fluid drainage and delivery tubes and electrical wires.For example, but without limitation, the retainer disclosed herein canalso be configured to receive and secure central venous catheters,peripherally inserted central catheters, hemodialysis catheters,surgical drainage tubes, feeding tubes, chest tubes, nasogastric tubes,scopes, as well as electrical wires or cables connected to external orimplanted electronic devices or sensors. One skilled in the art can alsofind additional applications for the devices and systems disclosedherein. Thus, the illustration and descriptions of the anchoring systemin connection with a Foley catheter are merely exemplary applications ofthe anchoring system.

The anchoring system described herein is especially adapted to arrestaxial movement of a catheter with a slippery coating, as well as holdthe catheter against the patient. For this purpose, the anchoring system10 utilizes one or more retention mechanisms. The anchoring systemaccomplishes this though without meaningfully impairing (i.e.,substantially occluding) the fluid flow through the catheter to a degreethat would create complications for a patient. As described below, suchretention mechanisms involve, among others, the shape of the channelthat retains a section of the catheter, retaining structure eitheraligned with or positioned within the channel, and/or a securementbarb(s) and/or friction ridge(s) that bites into the catheter bodywithout substantially occluding the catheter drainage lumen.

In certain embodiments, the anchoring system releasably engages thecatheter. This allows the catheter to be disconnected from the anchoringsystem, and from the patient, for any of a variety of known purposes.For instance, the healthcare provider may want to remove the catheterfrom the anchoring system to ease disconnection of the catheter from thedrainage tube or to clean the patient. In such embodiments, thedisengagement of the catheter from the anchoring system, however, can beaccomplished without removing the anchoring system from the patient. Anexemplary releasable strap that may be utilized with the anchoringsystem is described in U.S. Pat. No. 4,236,280, which is herebyincorporated by reference. Alternatively, a strap or other securingmeans is cut to thereby release the catheter from the retainer. Incertain embodiments that have a strap that is not integral to the base,the strap may be cut and replaced with an uncut strap. The cut strap isremoved from the conduit passing through the base. The uncut strap isthen inserted through the same conduit. The retainer is thereby readyfor re-engaging with the same or different catheter.

Before describing the present anchoring system in detail, a briefdescription of a Foley catheter is provided to assist the reader'sunderstanding of the exemplary embodiment that follows. As bestunderstood from FIG. 6 , the catheter 8 includes a proximal tip with aninflatable balloon (not shown) and a distal end 110. The distal end 110includes a Y-site 112 formed by an inflation branch 114 and a drainagebranch 116. The drainage branch 116 and the inflation branch 114 mergetogether at the Y-site 112. The lumens of these branches assume either acoaxial or side-by-side arrangement on the proximal side of the Y-site112 to form a main catheter body 118. On the distal side of the Y-site112, a webbing 120 extends between the two branches 114, 116 at a pointnext to the Y-site 112. The drainage branch 116 receives a connectorfitting 82. Preferably, the connector fitting 82 is semi-rigid and fitswithin a portion of the drainage branch 118 distal of the Y-site 112.The region of the drainage branch 118 which receives the semi-rigidconnector fitting 82 is preferably the portion of the catheter 8 that isretained by the retainer. The connector fitting 82 allows the retainerto compress the drainage branch 116 without significantly occluding thelumen within the drainage branch 116.

With reference now to FIGS. 1 and 2 , the anchoring system 10 includesan anchor pad 12 and a retainer 20. The anchor pad 12 secures theretainer 20 to a patient's skin. The anchor pad 12 has a lower adhesivesurface 16 which adheres to the skin of a patient and a roughened uppersurface 14 which supports the retainer 20. The retainer 20 is configuredto accept and retain a section of a Foley catheter 8 or other medicalarticle within the anchoring system 10. In the illustrated embodiment,the retainer 20 comprises a base 22 and a strap 24. The strap 24 may bedetachably or permanently secured to the base 22 and moveable betweenopen and closed positions.

To assist in the description of these components of the anchoring system10, the following coordinate terms are used. A “longitudinal axis” isgenerally parallel to the section of the catheter 8 retained by theanchoring system 10. A “lateral axis” is normal to the longitudinal axisand is generally parallel to the plane of the anchor pad 12. A“transverse axis” extends normal to both the longitudinal and lateralaxes. In addition, as used herein, “the longitudinal direction” refersto a direction substantially parallel to the longitudinal axis; “thelateral direction” refers to a direction substantially parallel to thelateral axis; and “the transverse direction” refers to a directionsubstantially parallel to the transverse axis. Also, the terms“proximal” and “distal”, which are used to describe the presentanchoring system 10, are used consistently with the description of theexemplary application. Thus, proximal and distal are used in referenceto the center of the patient's body. A detailed description of theanchoring system 10, and its associated method of use, now follows.

FIGS. 1 and 2 illustrate an anchor pad 12 which desirably comprises alaminate structure with an upper foam or woven material (e.g. tricot)layer (e.g., closed-cell polyethylene foam), and a lower adhesive layer.The lower adhesive layer constitutes the lower surface 16 of the anchorpad 12. The lower surface 16 desirably is a medical-grade adhesive andcan be either diaphoretic or non-diaphoretic, depending upon theparticular application. Such foam or woven material with an adhesivelayer is available commercially from Avery Dennison of Painsville, Ohio.Although not illustrated, it will be understood that the anchor pad 12can include suture holes in addition to the adhesive layer to furthersecure the anchor pad 12 to the patient's skin.

A surface of the upper foam layer constitutes an upper surface 14 of theanchor pad 12. The upper surface 14 can be roughened by corona-treatingthe foam or woven material with a low electric charge. The roughened orporous upper surface 14 can improve the quality of the adhesive joint(which is described below) between the base 22 and the anchor pad 12. Inthe alternative, the flexible anchor pad 12 can comprise a medical-gradeadhesive lower layer, an inner foam layer and an upper paper or otherwoven or nonwoven cloth layer.

A removable paper or plastic release liner 18 desirably covers theadhesive lower surface 16 before use. The liner 18 preferably resiststearing and desirably is divided into a plurality of pieces to easeattachment of the pad 12 to a patient's skin. In the illustratedembodiment, the liner 18 is split along a center line 19 of the flexibleanchor pad 12 in order to expose only half of the adhesive lower surface16 at one time.

The liner 18 length, as measured in the lateral direction, extendsbeyond the center line 19 of the anchor pad 12 and is folded over, orback onto the liner 18. This folded over portion defines a pull tab 17to facilitate removal of the liner 18 from the adhesive lower surface16. A healthcare provider uses the pull tab 17 by grasping and pullingon it so that the liner 18 is separated from the lower surface 16. Thepull tab 17 overcomes any requirement that the healthcare provider pickat a corner, edge or other segment of the liner 18 in order to separatethe liner 18 from the adhesive layer. The pull tab 17 of course can bedesigned in a variety of configurations. For example, the pull tab 17need not be located along a center line 19 of the anchor pad 12. Rather,the pull tab 17 can be located along any line of the anchor pad 12 inorder to ease the application of the anchor pad 12 onto the patient'sskin at a specific site. For example, an area of a patient's skin withan abrupt bend, such as at a joint, can require that the pull tab 17 bealigned toward one of the lateral ends of the anchor pad 12 rather thanalong the center line 19.

In the illustrated embodiment, the anchor pad 12 also desirably includesa pair of opposing concave sections 13, 15 that narrows the center ofthe anchor pad 12 proximate to the base 22. As a result, the lateralsides of the anchor pad 12 have more contact area which provides greaterstability and adhesion to a patient's skin.

The retainer 20 is principally formed by the base 22 and the strap 24.The illustrated strap 24 is a one-piece flexible plastic strap. Thestrap 24 comprises an elongated base portion 25 having a free end 27.The retainer 20 further comprises interengaging structure to couple thefree end 27 to the retainer 20. In the embodiment illustrated in FIG. 3, the interengaging structure comprises a latch mechanism 80 and aplurality of teeth members or protuberances 88. The latch mechanism 80is integrally formed at the end opposite from the free end 27. Thehealthcare provider introduces the free end 27 of the base portion 25into an opening 104 in the latch mechanism 80 so that the plurality ofteeth members 88 on the strap 24 with engage with the latch mechanism 80to lock the strap in a selected position. The free end 27 of the baseportion 25 may be tapered toward its extremity, which is rounded, so asto facilitate entry into opening 104 in the latch mechanism 80. Theplurality of teeth members or protuberances 88 are provided on the baseportion 25 near the free end 27 and facilitate gripping of the free end27 by the healthcare provider and locking the free end 27 in the latchmechanism 80. The latch mechanism 80 has one or more transverselyextending tooth or pawl 90 on the same side as the gripping teeth 88 onthe free end 27. The pawl 90 is adapted to cooperate with the teethmembers 88 on the base portion 25 so as to retain the base portion 25within the latch mechanism 80.

As most clearly shown in FIG. 3 , a conduit 74 extends through the base22 and is configured to receive the strap 24. Once inserted into theconduit 74, the strap 24 extends from both ends of the conduit 74. Incertain embodiments, the conduit 74 has a width that is less than thewidth of the base 22. The conduit 74 may have multiple portions alignedin the lateral direction and forming a single path for the strap 24. Anopening or window extending through the upper wall of the conduit 74 mayseparate the conduit portions. The opening or window may advantageouslyease insertion of the strap through the conduit 74. The portion of thestrap 24 that is exposed through the window forms a portion of thebottom surface of the channel 60.

The conduit may taper in width along at least a portion of its length.For example, the tapering or wide-mouth shapes of the conduit 74openings eliminate an edge or surface over which the strap 24 couldbind. The openings may further curve parallel with the strap 24 when thestrap 24 is in the closed position so as to smoothly guide the strap 24as the strap 24 exits the conduit 74 and wraps around the catheter.

Tapering the ends of the conduit 74 advantageously eases insertion ofthe strap into the conduit while maintaining a close fit between thewalls of the conduit 74 and the strap 24 between the tapering ends.Alternatively, the cross-section of the conduit 74 may substantiallyexceed the cross-section of the strap 24. Once inserted, the strap 24 isfed through the conduit 74 until the inserted end extends from the base22.

In the illustrated embodiment, the base 22 and strap 24 are separatelyformed and assembled to comprise the retainer 20. The retainer 20 isassembled by feeding the strap 24 through the conduit 74. Alternatively,the base 22 and strap 24 can be formed together as a unitary retainer20. This can be accomplished in any of a variety of ways well known tothose skilled in the art. For instance, the entire retainer 20 can beinjection molded in order to reduce fabrication costs. Exemplaryembodiments of a unitary retainer are described below with reference toFIGS. 9 through 28 .

In order to illustrate more clearly the design features of the retainer20 in FIGS. 1 through 8 , the anchor pad 12 of the anchoring system 10is not shown in FIGS. 3, 4, 6, 7, and 8 . In accordance with thepreferred embodiment, however, the entire anchoring system 10 isassembled in accordance with the above-description (e.g., the anchor pad12 is attached to the retainer 20) and is sterilized before use.

As will be apparent from the below description, several features of theretainer (e.g., the strap) desirably are flexible. Suitable ridged butflexible materials include, for example, but without limitation,plastics, polymers or composites such as polypropylene, polyethylene,polycarbonate, polyvinylchloride, acrylonitrile butadiene styrene,nylon, olefin, acrylic, polyester, as well as moldable silicon,thermoplastic urethane, thermoplastic elastomers, thermoset plastics andthe like. The illustrated base 22 may be formed by injection moldedusing polyethylene or polypropylene material or nylon. However, othermaterials can be utilized, and the retainer 20 can comprise a unitarybase 22 and strap 24.

With reference to FIG. 3 , the base 22 in the illustrated embodimentcomprises an elongated body of a generally parallelepiped shape. Thebase 22, however, can be configured in a wide variety of shapes as well,such as circular, square, triangular or the like in order to suit aparticular application. The width of the strap 24 desirably issufficiently long to provide stability to the catheter along its length.That is, the width of the retained catheter portion is sufficient toinhibit rocking of the catheter relative to the retainer 20 (i.e., toprevent the retainer 20 from acting as a fulcrum for the catheter).Also, the lateral dimension of the base 22 desirably allows thehealthcare provider to easily and naturally grip the base 22.

The base 22 includes first and second sides 26, 28. The first side 26lies generally at one lateral end of the base 22, and the second side 28lies at an opposite lateral end of the base 22.

A groove 30 or concave surface is formed on the base 22 between thefirst side 26 and the second side 28. In the illustrated embodiment, thegroove 30 has generally a truncated generally circular cross-sectionalshape. As best seen in FIG. 6 , the groove 30 is consistent in widthalong the longitudinal axis. In certain embodiments, the groove 30varies in width (i.e., in the lateral direction) along the longitudinalaxis. That is, in certain embodiments, the side walls of the groove 30diverge from each other in, for example, a generally linear manner fromone longitudinal side of the retainer 20 to the other longitudinal sideof the retainer.

The base 22 of the retainer 20 engages with the anchor pad 12. In theillustrated embodiment, the retainer 20 is rotatably mounted onto theanchor pad 12. The retainer 20 may be rotated by at least some degree,and preferably by 360°, relative to the anchor pad 12, as describedbelow. For this purpose and as most clearly shown in FIG. 5 , a mountingpost 226 is attached to the anchor pad 12 and a hole 232 is formed inthe base 22 of the retainer 20.

As best seen in FIGS. 3 through 5 , the mounting post 226 is attached tothe anchor pad 12. The through-hole 232 is formed in the base 22 of theretainer 20. The mounting post 226 and through-hole 232 allow theretainer 20 to pivot relative to the anchor pad 12. In the illustratedembodiment, the retainer 20 can be rotated 360° relative to a centralpivot point fixed to the anchor pad 12; however, the degree of rotationalso can be confined.

Relative rotation is advantageous to assist the medical provider inattaching and detaching the retainer 20 to the catheter (not shown).Relative rotation is also advantageous to assist the healthcare providerin adjusting the attached catheter or retainer assemblage so that thecatheter is less likely to become kinked or snagged on an object.Relative rotation is further advantageous to assist in positioning thecatheter in-line with the drainage lumen or other object. In addition,the healthcare provider need not precisely align the retainer relativeto an axis of the catheter before attaching the pad to the patient'sskin. The healthcare provider can coarsely align the anchoring system onthe patient, adhere the pad 12 to the patient's skin and then allow theretainer 20 to rotate so as to align the groove 30 of the base 22 withthe longitudinal axis of the catheter. The rotatable nature of theretainer 20 thus eases connection and disconnection of the catheter withthe retainer 20. The rotatable nature also permits the patient to movewithout kinking the catheter.

As best seen in FIGS. 4 and 5 , the illustrated mounting post 226comprises a pedestal 228 and a cap 230 configured for acceptance into athrough-hole 232 formed in the base 22 of the retainer 20. The pedestal228 is attached to and extends upwardly from a mounting base 242. Thepedestal 228 can have a variety of transverse heights depending upon theparticular application and the particular retainer to which itinteracts. For anchoring Foley catheters and for use with the retainerdescribed in FIG. 1 , the pedestal 228 desirably has a transverse heightslightly smaller than that of the base 22 at the location of the hole232; that is, the height can be about 1-5 mm, and more particularlyabout 3 mm; however, other heights are also possible. The illustratedpedestal 228 has a generally cylindrical shape, but can be configured ina variety of other shapes, which can match the shape of the hole 232 inthe retainer base 22. The diameter of the pedestal 228 is sufficient toperform its structural function of coupling the anchor pad 12 to thebase 22 without significantly bending or breaking and desirably has adiameter of about 1 to 8 mm and more particularly a diameter of about 6mm; however, larger or smaller diameters are also possible. Thus, thediameter of the pedestal 228 is desirably about twice the height of thepedestal 228. The pedestal 228 is flared at the bottom to form anannular fillet 246. The fillet 246 provides structural strength to thepedestal 228 to resist shear and other forces that can otherwise causethe pedestal to break off from the mounting base 242 or otherwise fail.

The cap 230 extends radially outward from the top portion of thepedestal 228. The cap 230 assists in coupling the mounting base 242 tothe base 22 by inhibiting separation of the pedestal 228 from the base22, as explained below. The radial width of the cap 230 can vary,depending upon the particular application, and desirably is about 1-5mm, and more particularly about 2 mm; however, larger or smaller widthsare also possible. The illustrated cap 230 has a cross sectional shapegenerally similar to that of the pedestal 228 for ease of manufacture,however, it can be configured in a variety of other cross sectionalshapes to generally match the shape of the through-hole 232 in the base22, which is described below. The cap 230 desirably extends beyond thecircumference of the pedestal 228 to assist in securely coupling themounting base 242 to the base 22. However, the cap 230 need notcircumscribe the entire pedestal 228 and can comprise only a singleradial member that extends outwardly from the pedestal 228. Thetransverse thickness of the cap 230 is sufficient to perform itsstructural function of coupling the mounting base 242 to the base 22without significantly bending or breaking and desirably has a thicknessof about 0.5 to 2 mm and more particularly a thickness of about 1 mm;however, larger or smaller thicknesses are also possible. A chamfer 234can be formed on an upper peripheral edge of the cap 230 to assist inthe assembly of the mounting post 226, as described below. Theillustrated chamfer 234 transversely extends for about one-half thethickness of the cap 230. In an embodiment, the mounting post 226further includes a slot extending axially through at least a portion ofthe mounting post 226. The slot facilitates coupling between themounting post 226/mounting base 242 and the retainer via thethrough-hole 232 by allowing portions of the cap 230 to flex radiallyinwards as the cap 230 is urged through the through-hole 232 duringassembly, as described below.

The mounting post pedestal 228 desirably has a smooth side surfaces tofacilitate sliding of the base 22 relative to the mounting post 226,such that the mounting post 226 provide a bearing surface for theretainer base 22. The top of the cap 230 additionally is smooth andplanar to present a surface that is generally flush with the surface ofthe base 22 within the channel. It is understood, however, that theconfiguration of the channel surface of the base 22, results in animperfectly flush surface between the base and the cap 230, although thetop of the cap 230 could be configured to match the configuration of thesurface of the base 22 and thereby present a perfectly flush surface.The mounting post 226 has a two-piece configuration for ease ofmanufacture and strength; however, the mounting post 226 canalternatively comprise a single component. Although the illustratedmounting post 226 is generally mushroom shaped with a generally flattop, the mounting post 226 can also be generally T-shaped, inverselyL-shaped and the like.

The mounting post 226 is desirably formed in unity with the mountingbase 242 for structural strength. However, the mounting post 226 and themounting base 242 can comprise separate components, as noted below. Themounting base 242 provides a larger footprint, relative to that of themounting post 226, such that in an embodiment at least a portion of theperimeter of the mounting post 226/mounting base 242 structure extendshorizontally beyond a perimeter of the retainer base 22, so that themounting post 226 can be more securely attached to the anchor pad 12 andinhibit unintended separation of the mounting post 226 from the anchorpad 12. For example, if the anchoring system 10 is adhered to the innerthigh of a bedridden patient, movement of the patient can generateforces on the anchoring system 10. Thus, the larger footprint which themounting base 242 provides, and which the mounting post 226 ispreferably in unity with, provides increased securement between themounting post 226 and anchor pad 12 and enhances the robustness of theanchoring system.

The mounting base 242 is generally planar to match the upper surface 14of the anchor pad 12. The illustrated mounting base 242 also has acircular configuration, with the mounting post 226 located at the centerof the base 242 so that the retainer 20 can centrally rotate on themounting base 242. However, the base can have other shapes as well.

Additionally and as most clearly shown in FIG. 3 , an upturned lip 244may circumscribes the perimeter of the mounting base 242 to form abarrier that inhibits inwardly directed radial forces from shearing orotherwise separating the retainer 20 or mounting post 226 from themounting base 242. The lip 244 may have a transverse height of about 1-5mm for this purpose. The lip diameter is slightly larger than thelateral width of the retainer 20 (i.e., larger by about 1 mm); however,the lip 244 can alternatively be arranged to radially abut the retainer20 when the retainer 20 rotates on the mounting base 242, or to providea radial clearance between the retainer 20 and the lip 244. The lip 244additionally does not extend above the bottom of the groove 30 and thusdo not present an edge about which the catheter could kink. The lip 244may be shorter than the mounting post 226. The lip 244 also does notinterfere with the free rotation of the retainer 20. However, themounting base 242 and the retainer 20 can include cooperating structurewhich establishes incremental angular positions of the retainer 20 as itrotates over the mounting base 242. This can be done by providing aplurality of ratchet teeth about the inner side surface of the lip 244and a cooperating tang formed on the retainer 20. In this manner, theorientation of the retainer 20 on the mounting base 242 can be set untila sufficient force is applied to the retainer to overcome the engagementbetween the tang and the corresponding ratchet teeth.

In the illustrated embodiment, as best understood from FIGS. 4 and 5 ,the base 22 of the retainer 20 has a through-hole 232 sized andconfigured to receive the post and more preferably to generally matchthat of the mounting post 226 so that the retainer 20 can rotaterelative to the anchor pad 12 about the mounting post 226. Theillustrated through-hole 232 extends through the base 22 and has a firstor lower diameter 236 and a second or upper diameter 238. The lowerdiameter 236 is slightly larger than that of the pedestal 228 and theupper diameter 238 is slightly larger than that of the cap 230. Thetolerance between the through-hole 232 and the mounting post 226desirably is about 0.1-0.5 mm and more particularly about 0.1-0.2 mm.Like the mounting post 226, the through-hole 232 has a smooth surface tominimize function when the retainer is rotated. A chamfer 240 cancircumscribe the lower portion of the lower diameter 236 to assist inthe assembly of the rotatable mounting post 226, as described below.

When assembled, the mounting post 226 is arranged within thethrough-hole 232 and secured to the anchor pad 12. In particular, thetop of the cap 230 is generally flush with the top of the base 22, thecap 230 is housed within the upper diameter 238, the pedestal 228 ishoused within the lower diameter 236, and the bottom of the pedestal 228is secured relative to the anchor pad 12. The mounting base 242 isdesirably secured to the upper surface 14 of the anchor pad 12 by asolvent bond adhesive, such as cyanoacrylate or other bonding material.One such adhesive is available commercially as Part No. 4693 from theMinnesota Mining and Manufacturing Company (3M).

One suitable assembly process, advantageously used when the mountingpost 226 and mounting base 242 are formed in unity, involves bonding thebottom of the mounting base 242 to the upper surface 14 of the anchorpad 12 and then urging the cap 230 of the mounting post 226 through thethrough-hole 232. The chamfer 240 that circumscribes the through-hole232 and the chamfer 234 that circumscribes the cap 230 cooperate toallow the cap 230 to deform and advance through the through-hole 232.Another suitable assembly process, advantageously used when the mountingpost 226 and mounting base 242 comprise separate components, involvesplacing the pedestal 228 through the through-hole 232 such that thepedestal 228 extends through the first diameter 236 while the cap 230catches on the second diameter 238, then bonding the bottom of thepedestal 228 to the mounting base 242, and then bonding the mountingbase 242 to the anchor pad 12. By this configuration, the retainer 20can rotate 360° relative to the anchor pad 12.

Alternatively, the base 22 is secured to the upper surface 14 by asolvent bond adhesive, such as cyanoacrylate or other bonding material.One such adhesive is available commercially as Part No. 4693 from theMinnesota Mining and Manufacturing Company (3M). In such an embodiment,the retainer 20 is fixedly attached and does not rotate relative to theanchor pad 12.

As also seen in FIG. 3 , the strap 24 has an elongate shape whichdesirably has a sufficient length to circumscribe the retained portionof the catheter. Each end of the strap 24 need not be the same size orshape. In certain embodiments, the strap 24 has a sufficientlongitudinal length to cover the groove 30 in the base and toaccommodate a portion of the latch mechanism 80. The latch mechanism 80may be located on an end of the strap 24 or on the base 22. The latchmechanism 80 operates to secure at least an end of the strap 24. Thestrap 24 also desirably is of a dimension which provides for easymanipulation. For example, the strap's size easily accommodates thegrasp of a healthcare provider.

As most clearly shown in FIG. 8 , when the strap 24 is in a closedposition an upper groove is formed on an inner side of the strap 24between the first and second sides 26, 28 of the base 22. The uppergroove corresponds generally to the lower groove 30 formed in the base22. In the illustrated embodiment, the strap 24 mechanically connects tothe base 22 while permitting the strap to slide in a lateral directionthrough the conduit 74 in the base 22. In the illustrated embodiment,the strap 24 is formed of flexible material, desirably of the samematerial from which the base 22 is comprised.

With the strap 24 in the open position, as illustrated in FIG. 7 , thegroove 30 in the base 22 is exposed. When in the open position, theretainer 20 is capable of receiving a portion (e.g., the drainage branch116) of the Foley catheter. As most clearly illustrated in FIG. 6 , thedrainage branch 116 receives a portion of the connector fitting 82. Theconnector fitting 82 fits within a portion of the drainage branch 118distal of the Y-site 112. The region of the drainage branch 118 whichreceives the semi-rigid connector fitting 82 is preferably the portionof the catheter 8 that is placed within the lower groove 30 and belowthe strap 24. The connector fitting 82 allows the retainer 20 tocompress the drainage branch 118 without significantly occluding thelumen within the drainage branch 116 due at least in part to thesemi-rigid nature of the connector fitting 82.

The closed position, as illustrated in FIG. 8 , is characterized by thestrap 24 lying in contact or near contact with the base 22 so as toposition the strap 24 above the lower groove 30. When in the closedposition, the retainer 20 surrounds the received portion of thecatheter.

The groove formed in the base 22 and the groove formed in the strap 24generally define a channel 60 when the strap 24 is in the closedposition. The groove formed in the strap 24 may have a longitudinallength that is the same, greater than, or less than the longitudinallength of the groove 30 in the base 22. Accordingly, the upper portionof an inner surface 69 of the channel 60 may be shorter or longer thatthe lower portion of the inner surface 69 of the channel 60 as measuredin the longitudinal direction.

The channel 60 is capable of receiving a portion or length of thecatheter 8 and is generally configured to house, grip and secure theaffected catheter portion against at a portion of the inner surface 69of the channel 60 in a contact area. The contact area may be disposedbetween the distal and proximal ends of the channel 60 and may extendbeyond either end of the channel 60. The contact area may be located onthe strap 24 and/or the base 22.

As illustrated in FIG. 6 , the catheter is positioned along thelongitudinal axis A so that the affected catheter portion which liesbelow the strap 24 when the strap 24 is in the closed position hasgenerally a continuous circular cross-sectional shape along thelongitudinal axis. Alternatively, the catheter 8 may be shifted in thedistal or proximal directions along the longitudinal axis so that adifferent portion of the catheter 8 lies under the strap 24. Forexample, the catheter 8 may be shifted in the distal direction relativeto its position illustrated in FIG. 6 so that the tapering portion ofthe catheter 8 located on the distal side of the Y-site 112 is locatedbelow the strap 24.

The channel 60 can have a variety of configurations, as discussed abovein connection with the grooves in order to accommodate a particularmedical article. In the illustrated embodiment, the channel 60 hasgenerally truncated circular cross-sectional shapes at its proximal end62 and distal end 64. The channel 60 may smoothly taper incross-sectional size from a smaller proximal end 62 to a larger distalend 64. For example, the channel 60 may generally have a truncatedV-shape that corresponds to a tapering portion of the catheter 8retained by the securement device.

In the embodiment illustrated in FIGS. 1-8 , the sides of the channel 60are generally straight and parallel with each other. The walls of thechannel 60 (and, thus, the grooves of the strap and base), however, neednot be straight. For example, the wall of the base groove 30 can have aconvex section that narrows the portion of the channel 60 so as tocorrespond in shape to the shape of the received portion of the drainagebranch 116 of the catheter. This channel shape furthers retention of thecatheter within the channel 60 to inhibit catheter movement through thechannel, as discussed below.

Although the channel 60 can take the form of various shapes dependingupon its application (i.e., depending upon a shape of the retainedportion of the medical article for which the retainer is designed to beused), the channel 60 does have a sufficient length in the longitudinaldirection to stabilize the catheter, rather than act as a fulcrum forthe catheter, as mentioned above. That is, the retainer receives asufficient length of the catheter to inhibit movement of the catheter inthe lateral, longitudinal and transverse direction (i.e., to inhibityaw, pitch and axial movement of the catheter), without kinking thecatheter. Also, the wide-mouth shape of the channel 60 at the proximalend 62 eliminates an edge or surface over which the catheter could kink.

When the strap 24 is closed, a section of the catheter 8 is capturedwithin the retainer 20. Thus, the retainer 20 at least restricts, if notprevents, lateral and transverse movement of the retained section of thecatheter 8.

Inhibiting movement of the catheter 8 in the longitudinal direction whenthe catheter 8 is secured within the channel 60 is desirablyaccomplished by one or more retention mechanisms associated with thecontact area of the channel 60. One such retention mechanism involvesthe shape of the channel 60 itself. The interaction between the shape ofthe channel 60 and a corresponding shape of the drainage branch 116inhibits proximal longitudinal movement. As best understood from FIG. 6, the proximal end 62 and the distal end 64 of the channel 60 receivethe drainage branch 116 of the catheter 8.

The interaction between the contact area on the inner surface 69 of theretainer channel 60 and the drainage branch 116 creates friction toinhibit longitudinal movement through the channel 60. The degree ofinterference between the catheter 8 and the retainer 20, however, cannotbe so great as to significantly occlude the catheter 8.

Another retention mechanism to inhibit axial movement of the catheter 8involves one or more friction ridges 70 located on the contact area onthe inner surface 69. In the illustrated embodiment, depicted by FIG. 6, the ridges 70 are integrally formed with the base 22 and project intothe channel 60. Because the illustrated embodiment also includessecurement barbs, which will be described below, the friction ridges 70are illustrated in phantom to convey that the ridges 70 can be usedtogether with or in the alternative to the securement barbs.

The ridges 70 are desirably of smooth solid construction; however, theycan be of hollow construction. The ridges 70 in the illustratedembodiment have generally triangular cross-sectional shapes and angletoward one or both ends of the channel 60. The ridges 70, however, canhave other cross-sectional shapes which would interfere with axialmovement of the catheter 8 through the channel 60.

Each of the ridges 70 desirably has a front wall or leading edge thatforms an angle of less than 90 degrees as measured between the frontwall and the inner surface 69. The ridges 70 slightly protrude into thechannel 60, desirably at a transverse distance of between 0.1 to 10 mmfor the given application. The ridges 70 also lie generally normal to alongitudinal axis through the channel 60.

When so arranged, the friction ridges 70 gently, but securely bite orpress into an outer surface of the drainage branch 116. Such contactdoes not occlude or otherwise meaningfully impair fluid flow in thecatheter lumen because of the compliant nature of the catheter bodymaterial and because of the degree to which the ridges 70 bite into thecatheter body. Occlusion is further inhibited with the insertion of theconnector fitting 82 into the drainage branch 116. This degree ofcontact, however, coupled with the angular orientation of the ridgesinhibits movement of the catheter 8, especially in a direction oppositeof that in which the ridges are angled.

Another possible retention mechanism to inhibit axial movement of thecatheter 8 relative to the retainer 20 involves one or more securementbarbs 33. Exemplary securement barbs 33 are illustrated in FIG. 12 . Thesecurement barbs can be used to retain the catheter in the longitudinaldirection. In certain embodiments, each barb 33 has a generally conicalshape with a blunt tip. The barb 33 may extend into the channel 60 by anamount ranging between about 0.1 mm and about 3 mm.

The securement barbs 33 may be arranged within the channel 60 tocooperate with one another. The barbs 33 advantageously are arrangedwithin the same general lateral plane (i.e., a plane defined by thelateral and transverse axes), and are spaced apart from one another. Inaddition, the barbs 33 desirably are spaced on generally oppositecontact areas on the inner surface 69 of the channel 60 in a staggeredarrangement. That is, the position of the barbs 33 alternate between thestrap surface and the base surface in the lateral direction. Theresulting overlapping pattern of the barbs 33 securely holds thecatheter 8 without imparting torque to the catheter 8 if pulled in alongitudinal direction.

Another possible retention mechanism to inhibit axial movement of thecatheter 8 relative to the retainer 20 involves an adhesive spot. Anadhesive spot may be advantageously disposed upon the inside of thestrap 24 within the upper groove or on the base 22 within the lowergroove 30. This adhesive spot may take the form of a glue dot. Such gluedots are desirably formed of a material which exhibits high resistanceto shear and which can be peeled off of the catheter without leaving aresidue. Such an adhesive is sold by All-Pak Inc. of New Berlin, Wis. aspart number GD-06 “Super High Tack Glue Dot.” Multiple glue dots may beused, or a single glue dot may be disposed on only one side of thechannel 60 of the retainer 20. It is not necessary for multiple gluedots to be used; a single glue dot disposed upon either the strap 24 orbase groove 30 may advantageously be used to provide greater frictionaland/or transverse forces between the retainer 20 and the catheter 8.

Furthermore, the adhesive spot need not be a single point of adhesive.In certain embodiments, the adhesive spot is a region composed of anelastic and compressively deformable material such Kraton polymercompounds. Such a compound includes Dynaflex G2706 available from GLSCorporation, as well as other thermoplastic elastomers or silicone orurethane epoxies.

This region also need not be round. In certain embodiments, a largeregion of the surface of the channel 60 may be covered with a suitablematerial, such as Kraton. For instance, the entire surface of the lowergroove 30 might be covered with a thin layer of adhesive toadvantageously provide additional traction and transverse bias betweenthe catheter and retainer.

Other means of producing an appropriate adhesive spot for use withvarious embodiments include without limitation: treating a portion ofthe surface of the channel 60 chemically or electrically to adjust itssurface friction or compressibility; spraying or spreading an adhesivecoating onto a portion of the grooves of the retainer; attachingpeel-off adhesive members to portions of the channel; injection moldingregions of adhesive or compressible material, such as Kraton, to aportion of the surface of the channel; or such other means as are knownin the art.

To firmly hold the drainage branch 116 within the channel 60, theretainer 20 includes interengaging structure to couple the free end 27to the retainer 20 in the closed position. As described with referenceto FIG. 1-8 , the latch mechanism 80 of the interengaging structure maybe fixedly attached to the base portion 25 of the strap 24. As describedwith reference to FIGS. 9-28 , the latch mechanism 80 of theinterengaging structure may be fixedly attached to the base 22 of theretainer 20. The interengaging structure may be releasable or not.

In the embodiment illustrated in FIGS. 1-8 , the interengaging structurecomprises a latch mechanism 80. The latch mechanism 80 may be formedwith the strap 24 as a unitary piece. The latch mechanism 80 is used tosecure the ends of the strap 24. In the illustrated embodiment, theinterengaging structure comprises a plurality of ratchet teeth 88 orserrations and a cooperating pawl 90, each formed on opposite ends ofthe strap 24. The ratchet teeth 88 or serrations may be on both sides ofthe strap to increase holding strength. The ratchet teeth or serrations88 are arranged on one end of the strap 24 while the pawl 90 is arrangedon the other end of the strap 24. However, these components can beflip-flopped on the ends of the strap 24. Of course other interengagingstructure known to one having ordinary skill in the art could be used.For example, Velcro, snaps, clips or the like could be employed tosecure the strap 24.

The latch mechanism 80 includes an opening 104 that receives the end ofthe strap 24 having the teeth or serrations 88. The entrance of theopening 104 may include chamfer edges. The chamfer edges slope inwardtoward the center of the opening 104 to cause the teeth 88 to bendinward when inserting the strap into the opening 104. The opening 104 inthe latch mechanism 80 may extend transversely to the plane of the baseportion 25. The opening 104 is slightly taller than the thickness of thebase portion 25 and is slightly wider than the width of the base portion25 near the free end 27 so as to slidingly receive the free end 27 andthe base portion 25. The opening 104 includes the pawl 90 against whichthe teeth 88 snap when the strap 24 is inserted through the opening 104forming the closed position.

In operation, the ends of the strap 24 bend toward the closed position.The relatively thin strip of material forming the strap 24 allows thestrap 24 to bend when finger pressure is exerted on the ends of thestrap to close it. The interaction between the teeth 88 and thecorresponding surface of the pawl 90 holds the strap 24 in the closedposition.

For embodiments having releasable interengaging structure, the structureis simply released to remove and replace a catheter within the channel60 of the retainer 20. The healthcare provider presses against aplatform to disengage the pawl 90 from the teeth 88 and open the latchmechanism 80. The healthcare provider can then open the strap 24 andexpose the inner groove 30 of the base 22.

In embodiments that are releasable, the same strap 24 may be used for anextended period of time, while permitting repeated attachment andreattachment of the catheter to the anchoring system 10. In addition,the latch mechanism 80 having a size greater than the conduit 74 ensuresthat the strap 24 will not be lost or misplaced when the catheter isdetached from the anchoring system 10 by pulling the tooth 88 end of thestrap 24. An exemplary releasable strap 24 is described in U.S. Pat. No.4,236,280 which is hereby incorporated by reference.

For embodiments having a non-unitary strap 24 and base 22 with anon-releasable interengaging structure, the healthcare provider mayremove a secured strap 24 by cutting the strap 24. A new strap 24 isthen inserted through the conduit 74 and re-secured around the catheter.Advantageously, the removal and replacement of the strap 24 occurswithout removing the anchor pad 12 from the patient.

As illustrated in FIGS. 7 and 8 , the healthcare provider can secure aFoley catheter (or other medical article) to a patient using theabove-described anchoring system (or a readily apparent modificationthereof). The healthcare provider first opens the retainer 20 to exposethe groove 30 on the base 22. Once opened, a drainage branch 116 portionthat surrounds a connector fitting 82 can be transversely aligned overthe groove 30. The catheter 8 can then be placed into the lower groove30. Once the catheter 8 is so aligned and placed into the groove 30, thestrap 24 is closed and latched, in the manner described above. Theshapes of the grooves 30 ensure that the channel 60 supports thedrainage branch 116 on at least diametrically opposed sides thereofalong the entire retained length of the drainage branch 116. This notonly enhances frictional contact between the retainer 20 and thecatheter 8, but it also prevents the catheter 8 from kinking or crimpingwithin the retainer 20 and thereby occluding the drainage branch 116.

If the retainer 20 employs projections that clamp onto or pin thecatheter within the channel 60, then this engagement between theretainer and the catheter would further secure the catheter in place. Ifthe catheter drainage branch 116 is pulled in the distal direction, thesecurement barbs bite into the drainage branch 116 and also opposemovement of the catheter branch 116 in this direction.

The retainer 20 thus inhibits longitudinal movement of the catheter 8relative to the retainer, even when used with a lubricated catheter. Theholding effect provided by each of the retention mechanisms, however,does not substantially occlude the drainage lumen of the catheter. Theinteraction of the ridges 70 and/or barbs 33 (i.e., the projection) onlyaffects the drainage branch 116 which surrounds a rigid connectorfitting 82. And although the projections bear against the catheter body,their limited bite does not significantly occlude or penetrate thedrainage branch 116.

The retainer can include only one retention member or possibly several;it need not include all. In addition, any combination of the retentionmembers (for example, an adhesive spot and securement barbs) in theretainer is also possible.

FIG. 9 is a perspective view of another embodiment of an anchoringsystem having a unitary retainer 20 a. The retainer 20 a is similar tothe retainer illustrated in FIG. 1 except that the strap 24 a and latchmechanism 80 a are fixedly attached to the base 22 a. Features common tothe anchoring systems in FIGS. 1 and 9 are identified with the samenumber prefix. The suffix “a” has been added to the number prefixesillustrated in FIGS. 9 through 18 .

The latch mechanism 80 a is releasable allowing the strap 24 a to beremoved from the latch mechanism 80 a. In certain embodiments, the strap24 a and retainer base 22 a are manufactured together as a single pieceretainer or separately manufactured and subsequently fixedly coupledtogether.

FIG. 10 is a perspective view of the retainer in FIG. 9 rotatablycoupled to an anchor pad 12 a. The catheter 8 is omitted from FIG. 10for drawing clarity. The anchoring system includes the anchor pad 12 aand the retainer 20 a. The anchor pad 12 a has a lower adhesive surface16 a which adheres to the skin of a patient and a roughened uppersurface 14 a which supports the retainer 20 a. The retainer 20 a isconfigured to accept and retain a section of a Foley catheter 8 or othermedical article.

In the illustrated embodiment, the retainer comprises a base 22 a, astrap 24 a, and interengaging structure. The strap 24 a comprises anelongated free end 27 a. The strap 24 a is permanently secured to a sideof the retainer base 22 a and moveable between open and closedpositions. A plurality of teeth members or protuberances 88 a areprovided on the free end 27 a which facilitate gripping of the free endby the healthcare provider.

The interengaging structure comprises a latch mechanism 80 a and theprotuberances 88 a. The latch mechanism 80 a is integrally formed withthe retainer base 22 a at the side opposite from the side secured to thestrap 24 a. The latch mechanism 80 a is used to secure the free end ofthe strap 24 a and includes a cooperating pawl 90 a. The pawl 90 a isadapted to cooperate with the plurality of teeth 88 a on the free end 27a so as to retain the free end 27 a within the latch mechanism 80 a.

FIG. 11 is a cross-sectional view of the anchoring system of FIG. 9 ,and illustrates the strap 24 a in a closed position with the catheter 8secured to the retainer 20 of the anchoring system by the releasablepawl 90 a and teeth 88 a. The healthcare provider introduces the freeend 27 a into an opening 104 a in the latch mechanism 80 a so that thecomplementary teeth on the strap 24 a and in the latch mechanism 80 awill engage to lock the strap in a selected position. The free end 27 amay be tapered toward its extremity, which is rounded, so as tofacilitate entry into opening 104 a in the latch mechanism 80 a. Thelatch mechanism 80 a has a plurality of transversely extending teeth 90a on the same side as the gripping teeth 88 a on the free end 27 a.

The latch mechanism 80 a includes an actuating member or latch 31 and atleast one locking pawl or tooth 90 a. The latch 31 is integrally moldedwith the latch mechanism 80 a so as to be deflectable relative theretoby means of its joinder at the upper end. When the latch 31 is pressed,the locking tooth 90 a is release from engagement with a selected tooth88 a on the strap 24 a so as to permit the strap to move in a releasedirection relative to the opening 104 a and thereby permit the strap 24a to be removed from the opening 104 a or adjusted as desired.

FIG. 12 is a perspective view of the retainer from FIG. 9 in an openposition. The strap 24 a illustrated in FIG. 12 extends in generally atransverse direction away from the retainer base 22 a. FIG. 13 is a topview of the retainer from FIG. 12 showing a plurality of barbs 33 b onportions of the contact areas on the base 22 a and on the strap 24 a.

FIG. 14 is a bottom view of the retainer from FIG. 12 showing athrough-hole 232 in the base 22 a of the retainer. FIG. 15 is a sideview of the retainer 20 a from FIG. 12 showing a plurality of ratchetteeth or serrations 88 a in the strap 24 a of the retainer. FIG. 16 is aside view of the retainer from FIG. 12 showing a groove 30 a portion ofthe channel 60. FIG. 17 is a cross-sectional view of the retainer fromFIG. 12 showing a releasable latch mechanism 80 a for the strap 24 a.FIG. 18 is a cross-sectional view taken along lines 18-18 in FIG. 16 andshows the through-hole 232 in the base 22 a of the retainer.

With reference to FIGS. 14 and 17 , the latch mechanism 80 a includes anintegrally formed lower bridging member 35 to which the latch 31 isjoined. The bridging member 35 extends between the sides of the latchmechanism 80 a. The sides of the latch mechanism 80 a serve to shieldthe latch 31 from sidewise interference, as well as to provideadditional strength to the latch mechanism 80 a.

Integrally formed on the latch 31 for movement therewith and extendinginto the opening 104 a is the locking teeth or pawl 90 a. In theembodiment illustrated in FIG. 17 , there is one locking tooth 90 a onthe inner surface of the latch 31 which defines a part of the opening104 a in the latch mechanism 80 a. The locking tooth 90 a iscomplementary to the teeth 88 a on the strap 24 a and extends asufficient distance into the opening 104 a to cooperate with theselected tooth 88 a so as to lock the strap 24 a in a selected positionabout the medical article.

In operation, the free end 27 a is inserted into the opening 104 a inthe latch mechanism 80 a until the strap 24 a is snugly drawn about themedical article to be secured. With the strap 24 a tightly drawn aboutthe medical article 8, the complementary teeth 88 a, 90 a are in alocked relationship as shown in FIGS. 9 and 10 . The edges of the teeth88 a normal to the strap 24 a abut the edges of the teeth 90 a normal tothe inner surface of opening 104 a. Retrogression or movement in arelease direction is prevented because the abutting planar faces of thelocking teeth 88 a are in engagement with like cooperating surfaces onthe selected cooperating teeth 90 a.

Release of the locking teeth 90 a from the teeth 88 a on the strap 24 ais attained by positive lateral force being applied upon the latch 31,so as to pivot the latch relative to the bridging portion 35 of thelatch mechanism 80 a. The lateral force releases the lock teeth 90 afrom engagement with the teeth 88 a on the strap 24 a. The strap 24 acan now be moved in a release direction in the opening 104 a so as topermit adjustment or removal of the strap 24 a from the medical article8.

FIG. 19 is a perspective view of another embodiment of an anchoringsystem having a unitary retainer 20 b. The retainer 20 b is similar tothe retainer illustrated in FIG. 9 except that the opening 104 b throughthe latch mechanism 80 b is not parallel relative to the anchor pad 12b. The opening 104 b is angled in a downward lateral direction andguides the elongated free end 27 b of the strap 24 b through the latchmechanism 80 b. The opening 104 b may be disposed such that the opening104 b is tangentially aligned with the outer circumference of theretained medical article.

In addition, the strap 24 b illustrated in FIG. 19 extends generally ina lateral direction away from the retainer base 22 b and parallel to theplane of the anchor pad 12 b when the strap 24 b is in the openposition. While only the retainer 20 b is illustrated in FIG. 22 , theentire anchoring system is assembled in accordance with theabove-description (e.g., the anchor pad 12 b is attached to the retainer20 b) and is sterilized before use. With the strap 24 b extending in thelateral direction and parallel to the anchor pad 12 b when the anchoringsystem is assembled, the anchoring system lies in a “low profile”position before use. That is, the strap 24 b of the retainer 20 bextends in the lateral direction to reduce the overall height of theanchoring system when in the open position, as measured in thetransverse direction.

The lateral projection of the strap 24 b allows the anchoring system,including the retainer 20 b and the anchor pad 12 b, to be easilypackaged within a pouch or other sterile container. The “low profile”position of the anchoring system further allows multiple pouches to beclosely packaged for storage or shipment. While lateral projection ofthe strap 24 b is preferred, in other embodiments the strap can extendin other directions (e.g., transversely) as is illustrated, for example,in FIG. 12 .

Once in the “low profile” position, the anchoring system will normallyremain in the “low profile” position until use at which time the strap24 b will be secured over the catheter 8 in the opposite lateraldirection and return to a “low profile” position. This position of theretainer 20 b when in use reduces the risk of the anchoring systeminterfering with any other activities being performed by the healthcareprovider.

As illustrated in FIG. 19 , the angled opening 24 b is more accessiblefor a healthcare provider to insert the elongated free end 27 b into theopening 104 b. The angled opening 104 b further reduces bending of thestrap 24 b between the outer circumference of the retained medialarticle and the entrance to the opening 104 b when inserting the freeend 27 b into the opening 104 b. By reducing the amount of bending tothe strap 24 b, the strap 24 b may more closely follow the outercircumference of the retained medical article and minimize gaps betweenthe retained medical article and the strap 24 b. Features common to theanchoring systems in FIGS. 9 and 19 are identified with the same numberprefix. The suffix “b” replaces the suffix “a” next to the numberprefixes illustrated in FIGS. 19 through 28 . Thus, the detaileddescription for features of the retainer 20 a applies with equal forceto the similar features found in the retainer 20 b.

FIG. 20 is a perspective view of the retainer 20 b in FIG. 19 rotatablycoupled to an anchor pad 12 b. The anchoring system includes the anchorpad 12 b and the retainer 20 b. The description of the anchor pad 12 bin FIG. 20 is the same as the description of the anchor pad 12 b in FIG.10 .

In the illustrated embodiment, the retainer 20 b comprises a base 22 b,a strap 24 b, and interengaging structure. The strap 24 b comprises anelongated free end 27 b. The strap 24 b is permanently secured to a sideof the retainer base 22 b and moveable between open and closedpositions. A plurality of teeth members or protuberances 88 b areprovided on the free end 27 b which facilitate gripping of the free endby the medical provider.

The interengaging structure comprises a latch mechanism 80 b and theprotuberances 88 b. The latch mechanism 80 b is integrally formed withthe retainer base 22 b at the side opposite from the side secured to thestrap 24 b. The latch mechanism 80 b is used to secure the free end ofthe strap 24 b and includes a cooperating pawl 90 b. The pawl 90 b isadapted to cooperate with a complementary tooth 88 b on the free end 27b so as to retain the free end 27 b within the latch mechanism 80 b.

FIG. 21 is a cross-sectional view of the anchoring system of FIG. 19 ,and illustrates the strap 24 b in a closed position with the catheter 8secured to the retainer 20 b of the anchoring system by a releasablepawl 90 b and teeth 88 b. The healthcare provider introduces the freeend 27 b into an angled opening 104 b in the latch mechanism 80 b sothat the complementary teeth on the strap 24 b and in the latchmechanism 80 b will engage to lock the strap in a selected position. Thestrap 24 b is preferably inserted in a downward lateral directionthrough the angled opening 104 b.

As illustrated in FIG. 19 , the degree of accessibility to the angledopening 24 b is improved for the healthcare provider to insert the strap24 b into the opening 104 b. FIG. 22 is a perspective view of theretainer 20 b from FIG. 19 in an open position. FIG. 23 is a top view ofthe retainer 20 b from FIG. 22 showing a plurality of barbs 33 b onportions of the contact areas on the base 22 b and on the strap 24 b.The description of the securement barbs 33 b in FIG. 22 is the same asthe description of the securement barbs 33 a in FIG. 12 .

FIG. 24 is a bottom view of the retainer from FIG. 22 showing athrough-hole 232 in the base 22 b of the retainer. FIG. 25 is a sideview of the retainer 20 b from FIG. 22 . FIG. 26 is a side view of theretainer from FIG. 22 showing the angled latch mechanism 80 b. FIG. 27is a cross-sectional view of the retainer from FIG. 22 showing theangled opening 104 b through the latch mechanism 80 b. FIG. 28 is across-sectional view taken along lines 28-28 in FIG. 26 and shows thethrough-hole 232 in the base 22 b of the retainer.

In operation, the free end 27 b is inserted in a downward transversedirection into the angled opening 104 b in the latch mechanism 80 buntil the strap 24 b is snugly drawn about the medical article to besecured. With the strap 24 b tightly drawn about the medical article 8,the complementary teeth 88 b, 90 b are in a locked relationship as shownin FIGS. 19 and 20 . The edges of the teeth 88 b normal to the strap 24b abut the edges of the teeth 90 b normal to the inner surface ofopening 104 b. Retrogression or movement in a release direction isprevented because the abutting planar faces of the locking teeth 88 bare in engagement with like cooperating surfaces on the selectedcooperating teeth 90 b.

Release of the locking teeth 90 b from the teeth 88 b on the strap 24 bis attained by positive lateral force being applied upon the latch 31,so as to pivot the latch relative to the bridging portion 35 of thelatch mechanism 80 b. The lateral force releases the lock teeth 90 bfrom engagement with the teeth 88 b on the strap 24 b. The strap 24 bcan now be moved in a release direction in the opening 104 b so as topermit adjustment or removal of the strap 24 b from the medical article8.

As is apparent from the foregoing description the retainer is readilyreleasable by means of the integral latch and can be easily refastenedand adjusted as desired. The present anchoring system thus provides asterile, tight-gripping, needle- and tape-free way to anchor a medicalarticle to a patient. The retainer thus eliminates use of tape, and ifprior protocol required suturing, it also eliminates accidental needlesticks, suture-wound-site infections and scarring. In addition, theretainer can be configured to be used with any of a wide variety ofcatheters, tubes, wires, and other medical articles. Patient comfort isalso enhanced and application time is decreased with the use of thepresent anchoring system.

The skilled artisan will also recognize the interchangeability ofvarious features from different embodiments. For instance, the angularorientation of the strap illustrated in FIG. 22 can be employed with thestrap illustrated in FIG. 1 . The upturned lip 244 illustrated in FIG. 3can be employed with the mounting base 242 illustrated in FIG. 21 .Thus, various features of the embodiments can be combined in order toadapt the anchoring system to a particular application.

Although this invention has been described in terms of certain preferredembodiments and suggested possible modifications thereto, otherembodiments and modifications apparent to those of ordinary skill in theart are also within the scope of this invention. Accordingly, the scopeof the invention is intended to be defined only by the claims whichfollow.

What is claimed is:
 1. A method of making an anchoring system,comprising: providing an anchor pad having an upper surface and a lowersurface, the lower surface including adhesive; attaching a mounting baseto the upper surface of the anchor pad, the mounting base including anintegral slotted mounting post formed as a single, molded piece, themounting post including a pedestal having a flared annular fillet at abase thereof, and a cap extending radially outward therefrom anddefining a circular outer perimeter, the mounting post including a slottraversing the cap; and coupling a retainer to the mounting base byinserting the mounting post into a through-hole of the retainer, thethrough-hole and the mounting post configured to permit rotation of theretainer on the mounting base, the retainer comprising a strap designedto frictionally interact with a catheter to inhibit longitudinalmovement of the catheter relative to the retainer.
 2. The method ofmaking according to claim 1, wherein the catheter is included with theanchoring system, the catheter comprising a connector fitting insertedinto a proximal end of a catheter tubular portion.
 3. The method ofmaking according to claim 2, wherein the catheter tubular portion is onebranch of a Y-site, and wherein the connector fitting comprises asemi-rigid material.
 4. The method of making according to claim 1,wherein the strap includes a latch mechanism configured to secure thestrap to the retainer in a closed position.
 5. The method of makingaccording to claim 4, wherein a surface texture of the strap comprisesprotrusions.
 6. The method of making according to claim 1, wherein theupper surface of the anchor pad comprises a roughened portion.
 7. Themethod of making according to claim 1, wherein attaching the mountingbase comprises centrally positioning the mounting base on the uppersurface, the anchor pad having an outer perimeter greater than the outerperimeter of the mounting base.
 8. The method of making according toclaim 1, wherein the retainer includes an interengaging structure thatsecures the strap such that the catheter is secured to the mountingbase, the interengaging structure including a latch disposed on a baseof the retainer and separated from the strap.
 9. The method of makingaccording to claim 8, wherein the interengaging structure comprises atwo-way, self-locking, releasable receptacle.
 10. The method of makingaccording to claim 1, wherein the retainer includes an interengagingstructure that secures the strap such that the catheter is secured tothe mounting base, the interengaging structure comprising a pawl whichreleasably fastens the strap to a base of the retainer.
 11. The methodof making according to claim 1, wherein coupling the retainer furtherincludes pressing the retainer over the mounting post until the cap isreceived in a corresponding groove of the retainer.
 12. The method ofmaking according to claim 1, wherein the retainer includes a concavechannel configured to receive the catheter.
 13. The method of makingaccording to claim 12, wherein the concave channel comprises asecurement barb designed to contact the catheter.
 14. The method ofmaking according to claim 12, wherein the concave channel comprises anadhesive disposed thereon, the adhesive designed to contact thecatheter.
 15. The method of making according to claim 1, wherein theretainer comprises a conduit, and wherein a portion of the strap isdisposed in the conduit.
 16. The method of making according to claim 1,wherein coupling the retainer further includes a first portion of thecap flexing radially inward relative to a second portion of the cap.